SmPC- Metformin SR 500mg Prolonged release Tablets: Change history
View Summary of Product Characteristics (SmPC- Metformin SR 500mg Prolonged release Tablets)
Last updated on this site: 31 Jul 2023
Variation Description:
Type IB, C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH (to update SPC section 4.6 and relevant section of PIL).
Type IB, C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH (to update SPC section 5.1)
SmPC sections updated - 4.6, 4.8, 5.1, 6.1, 10.
Last updated on this site: 31 Jul 2023
Variation Description:
Type IB, C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH (to update SPC section 4.6 and relevant section of PIL).
Type IB, C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH (to update SPC section 5.1)
SmPC sections updated - 4.6, 4.8, 5.1, 6.1, 10.
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Changes: (Updated: 31 Jul 2023)
Variation Description:
Type IB, C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH (to update SPC section 4.6 and relevant section of PIL).
Type IB, C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH (to update SPC section 5.1)
SmPC sections updated - 4.6, 4.8, 5.1, 6.1, 10.
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Changes: (Updated: 06 Dec 2022)
Section 4.4 – Addition of “Metformin may reduce vitamin B12 serum levels. The risk of low vitamin B12 levels increases with increasing metformin dose, treatment duration, and/or in patients with risk factors known to cause vitamin B12 deficiency. In case of suspicion of vitamin B12 deficiency (such as anaemia or neuropathy), vitamin B12 serum levels should be monitored. Periodic vitamin B12 monitoring could be necessary in patients with risk factors for vitamin B12 deficiency. Metformin therapy should be continued for as long as it is tolerated and not contra-indicated and appropriate corrective treatment for vitamin B12 deficiency provided in line with current clinical guidelines.”Section 4.8 – Addition of “Common • Vitamin B12 decrease/deficiency (see section 4.4)”, deletion too.
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Changes: (Updated: 21 Sep 2022)
initial upload